Opioid OverdosePhase 4NCT05876572
Blood Naloxone Levels Following Intradermal Injection in Humans
A Phase 4 study testing intradermal naloxone and microneedle injection in people with Opioid Overdose, run by Johns Hopkins University.
Trial summary
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Overdose
- What is being tested?
- intradermal naloxone and microneedle injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to participate in the informed consent process
- Good peripheral venous access for proposed pharmacokinetic sampling
- Has not taken an investigational drug within prior 30 days (or 5 half-lives, whichever is longer)
Who cannot join
- Allergy to Naloxone or vehicle constituents (namely parabens)
- Active substance use as defined by a positive screen for drugs of abuse within seven days of study participation
- History of substance use disorder
- Taking opiate/opioid medications for any indication
- Chronic pain disorder
- Pregnant or breastfeeding
Show all 9Show fewer
- Adults lacking capacity to consent, non-English speaking persons, or prisoners.
- Other medical history or active conditions deemed not safe for participation by the investigator
- Hematocrit <35%
About this study
Official title: A Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Naloxone Following Intradermal Injection in Humans
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.
Read the detailed description
Using approved drug formulations, injection devices, and assays, the investigators seek to determine the pharmacokinetics and pharmacodynamics of naloxone in human subjects using an intradermal delivery route. The long-term goal is to develop a product with better pharmacokinetic (PK) and pharmacodynamic (PD) properties than current delivery systems used in opioid overdose rescue. To the best of the investigators knowledge, this is the first study administering naloxone via an intradermal route in humans. Using an FDA-approved intranasal drug formulation, the investigators will administer 8mg/0.1ml of naloxone into the highly vascular dermal layer of the skin using microneedles in 3 healthy volunteer participants and measure plasma concentrations of naloxone for 60 minutes after injection. The investigators primary outcome measure is detectable levels of naloxone in plasma. Secondary outcome measures will be estimates of PK values derived from time versus concentration data.
- Conditions
- Opioid Overdose
- Being tested
- intradermal naloxone, microneedle injection
- Keywords
- naloxone, pharmacokinetics, pharmacodynamics, intradermal, Opioid receptor
- Medical subject headings
- Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradermal naloxoneDrug
One time 8 mg/0.1 mL dose of naloxone to be administered intradermally
microneedle injectionDevice
Intradermal delivery of naloxone using microneedle
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteer adults | Other | Not described Receives: Drug: intradermal naloxone; Device: microneedle injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Plasma Naloxone Concentration (ng/mL) using High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS).
Plasma Naloxone concentration (ng/mL) will be measured using HPLC-MS/MS at multiple timepoints following an intradermal injection of 8mg dose of Naloxone. The primary outcome is the presence or absence of detectable Naloxone at any time point. Time points include T0 (pre-Naloxone), 1, 2, 4, 6, 8, 12.5, 15, 30, 45, and 60 minutes after Naloxone treatment. Multiples of time points between participants will be taken as a simple mean average for that specific time point, and any samples below the limit of assay detection will be excluded from calculation.
Measured: up to 60 minutes
Secondary outcomes (3)
Measurement of the maximum plasma concentration (Cmax; ng/mL) of Naloxone using HPLC-MS/MS following a single 8mg dose of intradermally delivered Naloxone.
Using the data collected for the primary outcome, a secondary analysis will be done to determine the maximum concentration of Naloxone (Cmax) reached in plasma during the course of 60 minutes after an intradermal injection of Naloxone. Cmax will be taken as the highest mean average concentration (ng/ml) of plasma naloxone achieved at any given time point (times listed under primary outcomes). In conjunction with other data from this study, absorption rate and other important pharmacologic measures can be estimated to guide development of future phase 1 pharmacokinetic trials.
Measured: up to 60 minutes
Assessment of the time (minutes) at which the maximum Naloxone concentration (ng/mL) is detected in plasma (Tmax) by HPLC-MS/MS after a single 8mg dose of intradermally delivered Naloxone.
Using the data collected for the primary outcome, another secondary analysis will be done to determine the time at which Naloxone concentration reaches a maximum during the course of 60 minutes after an intradermal injection of Naloxone. This will be determined by selecting the time point at which the highest mean average concentration (ng/ml) of plasma Naloxone is achieved among any of the times point listed under primary outcomes. In conjunction with other data from this study, absorption rate and other important pharmacologic measures can be estimated to guide development of future phase 1 pharmacokinetic trials.
Measured: up to 60 minutes
Assessment of Naloxone exposure (mg*h/L) over 60 minutes (AUC 0-60) as measured by HPLC-MS/MS of plasma samples collected after a single 8mg dose of intradermally delivered Naloxone.
Additionally, Naloxone concentrations (ng/mL) taken from the above experiment will be averaged (mean) for each time point and then used to calculate the Area Under the Curve (AUC; mg*h/L) as a measure of Naloxone exposure over the course of 60 minutes after intradermal Naloxone injection. In conjunction with other data from this study, absorption rate and other important pharmacologic measures can be estimated to guide development of future phase 1 pharmacokinetic trials.
Measured: up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study startAug 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Currently does not have active IRB status
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- DEKA S.r.l.
- Responsible party
- Sponsor
- Investigators
- Kathryn Rosenblatt, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876572
- Sponsor's protocol ID
- IRB00380585
- Status last verified
- Oct 2024
- First submitted
- 10 May 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Naloxone Following Intradermal Injection in Humans
- ClinicalTrials.gov ID
- NCT05876572
- Acronym / sponsor ID
- IRB00380585
- Conditions
- Opioid Overdose
- Keywords
- naloxone, pharmacokinetics, pharmacodynamics, intradermal, Opioid receptor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Currently does not have active IRB status
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- DEKA S.r.l.
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.
Detailed description
Using approved drug formulations, injection devices, and assays, the investigators seek to determine the pharmacokinetics and pharmacodynamics of naloxone in human subjects using an intradermal delivery route. The long-term goal is to develop a product with better pharmacokinetic (PK) and pharmacodynamic (PD) properties than current delivery systems used in opioid overdose rescue. To the best of the investigators knowledge, this is the first study administering naloxone via an intradermal route in humans. Using an FDA-approved intranasal drug formulation, the investigators will administer 8mg/0.1ml of naloxone into the highly vascular dermal layer of the skin using microneedles in 3 healthy volunteer participants and measure plasma concentrations of naloxone for 60 minutes after injection. The investigators primary outcome measure is detectable levels of naloxone in plasma. Secondary outcome measures will be estimates of PK values derived from time versus concentration data.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteer adults | Other | Drug: intradermal naloxone, Device: microneedle injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to participate in the informed consent process
- Good peripheral venous access for proposed pharmacokinetic sampling
- Has not taken an investigational drug within prior 30 days (or 5 half-lives, whichever is longer)
Key exclusion criteria (9 listed)
- Allergy to Naloxone or vehicle constituents (namely parabens)
- Active substance use as defined by a positive screen for drugs of abuse within seven days of study participation
- History of substance use disorder
- Taking opiate/opioid medications for any indication
- Chronic pain disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intradermal naloxoneOne time 8 mg/0.1 mL dose of naloxone to be administered intradermally | Drug | healthy volunteer adults |
| microneedle injectionIntradermal delivery of naloxone using microneedle | Device | healthy volunteer adults |
Primary outcome
Detection of Plasma Naloxone Concentration (ng/mL) using High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS).
Time frame: up to 60 minutes
Plasma Naloxone concentration (ng/mL) will be measured using HPLC-MS/MS at multiple timepoints following an intradermal injection of 8mg dose of Naloxone. The primary outcome is the presence or absence of detectable Naloxone at any time point. Time points include T0 (pre-Naloxone), 1, 2, 4, 6, 8, 12.5, 15, 30, 45, and 60 minutes after Naloxone treatment. Multiples of time points between participants will be taken as a simple mean average for that specific time point, and any samples below the limit of assay detection will be excluded from calculation.
3 secondary outcomes
Measurement of the maximum plasma concentration (Cmax; ng/mL) of Naloxone using HPLC-MS/MS following a single 8mg dose of intradermally delivered Naloxone.
Time frame: up to 60 minutes
Assessment of the time (minutes) at which the maximum Naloxone concentration (ng/mL) is detected in plasma (Tmax) by HPLC-MS/MS after a single 8mg dose of intradermally delivered Naloxone.
Time frame: up to 60 minutes
Assessment of Naloxone exposure (mg*h/L) over 60 minutes (AUC 0-60) as measured by HPLC-MS/MS of plasma samples collected after a single 8mg dose of intradermally delivered Naloxone.
Time frame: up to 60 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Opioid Overdose
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Rosenblatt, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intradermal naloxone and microneedle injection in people with Opioid Overdose, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Plasma Naloxone Concentration (ng/mL) using High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS). (time frame: up to 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.